MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-26 for UNSPECIFIED BD PEN NEEDLE UNKNOWN manufactured by Becton Dickinson.
[185199811]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_2__; occurrence: unable to perform complaint lot history check due to an unknown lot number for harm bleeding, does not attach/detach & hyperglycemia. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform complaint lot history check due to an unknown lot number for harm bleeding, does not attach/detach & hyperglycemia. Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Patient Sequence No: 1, Text Type: N, H10
[185199812]
It was reported that the unspecified bd pen needle was involved with a serious injury in the form of an underdose. The lay user/consumer was unable to administer their entire medication dosage. No information has been received to suggest that the lay user/consumer sought/received medical intervention from a health care professional as a result of the defect. The following information was provided by the initial reporter: material no: unknown batch no: unknown. Verbatim: bleeding when put the shot in [injection site haemorrhage] patient possibly did not get full dose of forsteo due to bleeding at injection site, no ae [accidental underdose] medical history and concomitant medications were not provided. The patient received teriparatide (rdna origin) injections (forteo), via a pre-filled pen, at an unknown dose, frequency and route of administration for the treatment of an unknown indication, beginning on an unknown date in (b)(6) 2019. On an unknown date, at the beginning of the treatment, at an unspecified time, she experienced bleeding when she put the shot in, now the bleeding was more frequent and she was getting a little more blood that she was getting before. She was concerned losing effectiveness of the medication as she was bleeding and the medication was coming out in blood (not sure if medication was coming with blood). She was squeezing the injection site. She could not hold the medication without holding it tightly as she was not heavy (she had not fat to put injection into). She was using ultrafine needles (brand size, unspecified). Occasionally instead of getting the blood in the injection site where the needle was, a couple of times it was more than that a line of blood (unable to clarify further). Additionally, she felt successful injection in her abdomen over her thigh, since she had trouble-getting needle straight into her thigh. She bleed less when she injected in abdomen. She had trouble screwing the needle on the device. On an unknown date in (b)(6) 2020, while on teriparatide therapy, she experienced quite a bit of pain in ankles. Sometime in (b)(6) 2020, while on teriparatide therapy, she experienced trouble with ankles. Outcome of the events, corrective treatment and teriparatide therapy status was not provided. The operator of device was patient and her training status was not provided. The general device model duration was unknown but it was started in (b)(6) 2019. Suspect device duration of use was not provided. The action taken with the suspect device was unknown and evaluation would be performed if device was returned. The initial reporting consumer did not provide any opinion of relatedness for injection site bleeding and accidental underdose with teriparatide drug and device, while did not know about the relatedness for the remaining events with teriparatide drug and device. Update 16-mar-2020: additional information was received from the initial consumer reporter on 11-mar-2020 (both documents received on 11-mar-2020, were processed together). Added address of the patient, gender as female, two non-serious event of injection site bleeding and accidental underdose. Updated teriparatide device as suspect. Updated narrative accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00505 |
| MDR Report Key | 9886833 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNSPECIFIED BD PEN NEEDLE |
| Generic Name | PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-26 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |