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 30G X 5/16 IN ATTACHED NEEDLE 305934 manufactured by Bd Medical - Diabetes Care.
[184892448]
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 plunger rod broken 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 a broken plunger rod. 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 were zero (0) notifications noted that pertained to the complaint. 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. 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 (1) syringe 0. 5ml 30g tw 8mm from material 305934; batch 8331575. A visual evaluation of (1) syringe found a syringe that has a broken thumb press. The syringe nor the plunger do not appear to be bowed. There is a light coverage of silicone on the inside of the barrel and the plunger is easy to pull out of the syringe, however breakout and sustaining test cannot be performed as there is no thumb press on the syringe. There was no other damage to the syringe. Process summary: automatic syringe assembly machine, which feeds 1/2cc, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components. This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials. This type of defect can occur when a plunger head is caught in the dial causing all other plungers to break off until it is removed. Investigation: l2l dispatch 87099 was for plunger thumb presses breaking off at the inspection dial (station 1). Root cause: removed broken plunger head from the dial and adjusted the air (air jets) on the dead blocks. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[184892449]
It was reported that 1/2 ml bd safetyglide? Insulin syringe with 30g x 5/16 in attached needle plunger is broken. This was discovered before use. The following information was provided by the initial reporter: broken plunger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2020-00183 |
| MDR Report Key | 9767825 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-02-15 |
| 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 30G X 5/16 IN 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 Age | DA |
| 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 |