MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-26 for UNSPECIFIED BD? PEN NEEDLE UNKNOWN manufactured by Becton Dickinson.
[185199321]
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. Medical 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 hyperglycemia. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. If samples are received in the future the complaint will be reopened for further investigation. Unable to perform dhr check due to an unknown lot number for 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.
Patient Sequence No: 1, Text Type: N, H10
[185199322]
It was reported that unspecified bd? Pen needle was unable to deliver insulin and caused blood sugar levels to be high. This was discovered during use. The following information was provided by the initial reporter: material no: unknown batch no: unknown. It was reported that the blood sugar levels were high as insulin glargine dose was not administered. Information regarding the outcome of the event, corrective treatment and insulin glargine action taken was not reported. The patient was the operator of the suspect pen, however her training status was not reported. The general model duration of use and the suspect pen duration of use was not reported. The action taken of the suspect pen was not reported and its return was not expected. Verbatim: blood sugar levels were high [blood glucose increased]. The patient did not administer basaglar due to a possible issue with kwikpen device, ns (blood glucose increased) [product dose omission]. Case description: this solicited case, reported by a consumer who was participating in a patient assistance program (pap). Medical history and concomitant medications were not reported. The patient received insulin glargine (basaglar) injections via pre-filled pen (kwikpen). Dosage regimen, route of administration, indication for use and start therapy date were not reported. On (b)(6) 2020, she had an issue with four kwikpens from the same box and lot number as insulin glargine was not being dispensed, due to this, it was believed insulin glargine dose was missed. Bd needles 23gx4mm were used and priming with two units was performed prior every injection. On (b)(6) 2020, blood sugar levels were high as insulin glargine dose was not administered. Information regarding the outcome of the event, corrective treatment and insulin glargine action taken was not reported. The patient was the operator of the suspect pen, however her training status was not reported. The general model duration of use and the suspect pen duration of use was not reported. The action taken of the suspect pen was not reported and its return was not expected. The reporting consumer did not provide causality assessment between the events and insulin glargine but related the events to the suspect kwikpen. Analysis statement: company assessment of relatedness ((b)(6) 2020): the events blood glucose increased and product dose omission are not reasonably possibly related to insulin glargine because blood glucose increased is commonly associated with diabetes mellitus, the approved indication for this drug, and product dose omission is external to drug action.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00507 |
| MDR Report Key | 9887077 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-19 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| 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 |