MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALRG SFTYGLD 1ML W/NDL 26X3/8 IB; PISTON SYRINGE

Model Number	305951
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: customer returned (8) loose 1ml safetyglide syringes without any packaging.Customer states that there are mixed syringes.All returned syringes were examined and no defects were observed on the returned samples.Since the samples were returned loose without any packaging the mixed product issue cannot be confirmed.A review of the device history record was completed for batch# 0141098.All inspections and challenges 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: unconfirmed: bd was not 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: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the above, no additional investigation and no capa/sa is required at this time.
Event or Problem Description
It was reported that syringe alrg sftygld 1ml w/ndl 26x3/8 ib came with a mix of product types.The following information was provided by the initial reporter: material no: 305951, batch no: 0141098.It was reported mixed syringes.Verbatim: per customer's response on (b)(6) 2021.We opened the boxes on (b)(6) 2021.We are still finding the insulin syringes in sterile boxes daily.No one was injured.I had to throw away some of the needles as we had contaminated the needles with serum.I will send the needles that did not get contaminated via (b)(6).Reported issue: report that 1 case of item had mixed syringes in each box.About 40 insulin syringes were mixed into the case and she cannot use these.Customer disposition request: replacement.
Additional Manufacturer Narrative
H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned (8) loose 1ml safetyglide syringes without any packaging from lot # 0141098 product # 305951 with the reported issue of ¿mixed syringes¿.All returned syringes were examined and no defects were observed on the returned samples.Since the samples were returned loose without any packaging the mixed product issue cannot be confirmed.A review of the device history record was completed for batch# 0141098.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.
Event or Problem Description
It was reported that syringe alrg sftygld 1ml w/ndl 26x3/8 ib came with a mix of product types.The following information was provided by the initial reporter: material no: 305951 batch no: 0141098.It was reported mixed syringes.Verbatim: per customer's response on 01/20/2021.We opened the boxes on 1/15/21.We are still finding the insulin syringes in sterile boxes daily.No one was injured.I had to throw away some of the needles as we had contaminated the needles with serum.I will send the needles that did not get contaminated via fedex.Reported issue: report that 1 case of item had mixed syringes in each box.About 40 insulin syringes were mixed into the case and she cannot use these.Customer disposition request: replacement.

• Brand Name: SYRINGE ALRG SFTYGLD 1ML W/NDL 26X3/8 IB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11313534
• Report Number: 1920898-2021-00182
• Device Sequence Number: 14092139
• Product Code: MEG
• UDI-Device Identifier: 30382903059516
• UDI-Public: 30382903059516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/12/2021

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: 05/31/2025
• Device Model Number: 305951
• Device Catalogue Number: 305951
• Device Lot Number: 0141098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1