MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SYRINGE 0.5ML 30GA 8MM 10BAG 500 PL/WG; NEEDLE

Catalog Number	928854
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	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 bd¿ syringe 0.5ml 30ga 8mm 10bag 500 pl/wg had moisture inside of the syringe.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.928854.Batch no.7352875.It was reported that there was moisture inside of the syringe.Verbatim: (b)(6) pharmacist reported on behalf of consumer that there was moisture inside of the syringe before injection.Consumer does not re-use syringe, occurrence date is unknown.Lot # 7352875, product # 928854, expiration date was not provided.Pharmacist gave consumer a replacement box, sending mail kit and replacement product to pharmacy.
Event or Problem Description
It was reported that bd¿ syringe 0.5ml 30ga 8mm 10bag 500 pl/wg had moisture inside of the syringe.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.928854, batch no.7352875.It was reported that there was moisture inside of the syringe.Verbatim: walgreens pharmacist reported on behalf of consumer that there was moisture inside of the syringe before injection.Consumer does not re-use syringe, occurrence date is unknown.Lot # 7352875, product # 928854, expiration date was not provided.Pharmacist gave consumer a replacement box, sending mail kit and replacement product to pharmacy.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (3) 1/2cc, 8mm, 30g walgreens syringes in an open poly bag from lot # 7352875.Customer states that there was moisture inside of the syringe before injection.All returned syringes were examined and all exhibited clear droplets of material inside the barrels.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 insulin.This material would not have been acquired during the manufacturing process.A review of the device history record was completed for batch# 7352875.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200731829] noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure, although this material would not be acquired from the manufacturing process and is not a manufacturing defect.This material may have been acquired from the customer.Insulin would not have been acquired during the manufacturing process.

• Brand Name: BD¿ SYRINGE 0.5ML 30GA 8MM 10BAG 500 PL/WG
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8480144
• Report Number: 1920898-2019-00315
• Device Sequence Number: 16624900
• Product Code: FMI
• UDI-Device Identifier: 00311917025285
• UDI-Public: 00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: Lay User/Patient
• Device Catalogue Number: 928854
• Device Lot Number: 7352875
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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