MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number 305950

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the samples were received by bd for evaluation.A quality engineer was able to review the returned (6) loose 1ml bd safetyglide allergy syringes without any packaging from lot # 0104234, product #: 305950 with the reported issue of black part of the plunger is too big for the syringe and we are unable to pull back on the plunger to draw up the allergy extract into the syringe.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch#: 0104234.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the above, no additional investigation and no capa/sa is required at this time.Investigation conclusion: a complaint history check was performed and this is the 4th related complaint reported with the defect/condition of stopper defective with lot #0104234 regarding item #305950 a review of the applicable fmea/eura (doc# 10000353837 and rev#3) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Investigation summary: customer returned (6) loose 1ml bd safetyglide allergy syringes without any packaging.Customer states that the black part of the plunger is too big for the syringe and we are unable to pull back on the plunger to draw up the allergy extract into the syringe.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0104234.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customers 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 cannot be determined at this time as the issue is unconfirmed.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that 9 syringe alrg sftygld 1ml w/ndl 27x1/2 rb experienced difficult plunger movement.The following information was provided by the initial reporter: material no: 305950, batch no: 0104234.The material is the safetyglide 1 ml 27g 1/2 ref 305950, lot # 0104234.The issue we are having is that it seems that the black part of the plunger is too big for the syringe and we are unable to pull back on the plunger to draw up the allergy extract into the syringe.We have had over 25 syringes this week from the same lot number that the complaint was made.

• Brand Name: SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11263583
• MDR Text Key: 245493930
• Report Number: 1920898-2021-00139
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903059508
• UDI-Public: 00382903059508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305950
• Device Lot Number: 0104234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1