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

Catalog Number	305945
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe sftygld 1ml w/ndl 27x1/2 rb had foreign matter.The following information was provided by the initial reporter: the safety mechanism seems flimsy and barely covers the needle.
Event or Problem Description
It was reported that syringe sftygld 1ml w/ndl 27x1/2 rb had foreign matter.The following information was provided by the initial reporter: the safety mechanism seems flimsy and barely covers the needle.
Additional Manufacturer Narrative
The following fields were corrected.D10: device available for eval no.D10: returned to manufacturer on: na.H6: the photo was received by bd for evaluation.A quality engineer was able to review the photo of a 1ml, 13mm, 27g bd safetyglide syringes from lot # 1046698 regarding item # 305945 with the reported issue that the ¿safety mechanism seems flimsy and barely covers the needle¿.The photo was examined and the safety mechanism appears to cover the cannula.However, it is difficult to determine of the safety mechanism has fully engaged properly solely from the attached photo without the physical sample.A review of the device history record was completed for batch# 1046698.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained 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.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the photo(s) received the investigation concluded that bd was able to duplicate or confirm the indicated failure.H3 other text : see h10.

• Brand Name: SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
• Common Device Name: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12629440
• Report Number: 1920898-2021-01075
• Device Sequence Number: 4522606
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: 00382903059454
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 305945
• Device Lot Number: 1046698
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown