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

Model Number	305540
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use the needles were discovered to have foreign matter on tip with a bd syringe allergy 1ml w/ndl 27x1/2 rb.The following information was provided by the initial reporter: it was reported that numerous needles were found to have a plastic piece on the end of the needles.
Event or Problem Description
It was reported that prior to use the needles were discovered to have foreign matter on tip with a bd syringe allergy 1ml w/ndl 27x1/2 rb.The following information was provided by the initial reporter: it was reported that numerous needles were found to have a plastic piece on the end of the needles.
Additional Manufacturer Narrative
H.6 investigation summary: photos were received by bd for evaluation.A quality engineer was able to review the photos of a 1ml syringes in an open tray from lot # 7257954, regarding item # 305540 with the reported issue that numerous needles were found to have a plastic piece on the end of the needles.The photos were examined, and no foreign matter was observed on any of the syringes shown.A review of the device history record was completed for batch# 7257954.All inspections 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.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause cannot be determined at this time.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-04-07 h.6.Investigation summary customer returned (31) 1ml, 13mm, 27g bd allergy syringes in open trays from lot # 7257954.Customer states that numerous needles were found to have a plastic piece on the end of the needles.All returned syringes were examined and 2 syringes exhibited a piece of material on the cannula.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely polyethylene.A review of the device history record was completed for batch# 7257954.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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.H3 other text : see h.10.
Event or Problem Description
It was reported that prior to use the needles were discovered to have foreign matter on tip with a bd syringe allergy 1ml w/ndl 27x1/2 rb.The following information was provided by the initial reporter: it was reported that numerous needles were found to have a plastic piece on the end of the needles.

• Brand Name: BD SYRINGE ALLERGY 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
• MDR Report Key: 9751123
• Report Number: 1920898-2020-00171
• Device Sequence Number: 14183379
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: 30382903055402
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/03/2022
• Device Model Number: 305540
• Device Catalogue Number: 305540
• Device Lot Number: 7257954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020; 02/03/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/06/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other