MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-02-28 for 1/2 ML BD SAFETYGLIDE? INSULIN SYRINGE WITH ATTACHED NEEDLE 305934 manufactured by Bd Medical - Diabetes Care.
[184892717]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for scale marking light/illegible on lot # 8331575. Investigation summary: customer returned (1) 1/2cc, 8mm, 30g bd safetyglide insulin syringe in an open blister pack from lot # 8331575. Customer states that the plunger is broken. The returned syringe was examined and exhibited smeared ink printed on the barrel. Manufacturing (holdrege) will be notified of this issue. A review of the device history record was completed for batch# 8331575. All inspections were performed per the applicable operations qc specifications. There was one (1) notification [(b)(4)] noted for print out of registration. Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer? S indicated failure (smeared scale markings). 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: as per investigation completed by manufacturing under investigation child (b)(4), on 25feb2020, holdrege received a photo of a syringe 0. 5ml 30g rtw 8mm syringe from material 305934; batch 8331575. A visual evaluation of the syringe found double and shadow print throughout the numbers printed on the barrel. Process summary: the barrel printer applies ink from a substrate to a molded barrel that has been treated with corona to get a good adhesion of the ink to the molded barrel. The barrels are then transitioned to the oven for the ink to cure. The cured product exits the oven chute for transfer to the next operation. Root cause: dispatch 86780? On 17 dec 2019 double print coming off ct printer. Corrective action: print pads were changed. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[184892718]
It was reported that 1/2 ml bd safetyglide? Insulin syringe with attached needle had scale marking issues. This was discovered before use. The following information was provided by the initial reporter: scale unclear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2020-00182 |
| MDR Report Key | 9767819 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-11-27 |
| Date Added to Maude | 2020-02-28 |
| 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 | BD MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1/2 ML BD SAFETYGLIDE? INSULIN SYRINGE WITH ATTACHED NEEDLE |
| Generic Name | SYRINGE, ANTISTICK |
| Product Code | MEG |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-25 |
| Catalog Number | 305934 |
| Lot Number | 8331575 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |