MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Catalog Number 328468

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Visual Impairment (2138)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs caused a serious injury in the form of intraocular inflammation/hazy vision.The following information was provided by the initial reporter: material no.: 328468 batch no.: 7325644.It was reported that an intraocular inflammation complaint had been submitted involving the bd insulin syringes.There was a call to discuss user facility's questions.As part of that discussion, they disclosed that the reason they were making inquiries was that an intraocular inflammation complaint involving bd insulin syringes had been submitted.The individual reporting the complaint communicated that they had used bd insulin syringes to perform intraocular injection of their drug.At that time of the call it was not clear whether the complaint had been submitted to bd; they are still in the process of verifying but i am submitting this conservatively.I will forward any additional information i receive, but bear in mind they may be directing the individual who reported originally to report directly to bd.Date of awareness: (b)(6) 2019, catalog number: 328468, lot number: 7325644.

Event Description

It was reported that an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs caused a serious injury in the form of intraocular inflammation/hazy vision.The following information was provided by the initial reporter: material no.: 328468 batch no.: 7325644 it was reported that an intraocular inflammation complaint had been submitted involving the bd insulin syringes.There was a call to discuss user facility's questions.As part of that discussion, they disclosed that the reason they were making inquiries was that an intraocular inflammation complaint involving bd insulin syringes had been submitted.The individual reporting the complaint communicated that they had used bd insulin syringes to perform intraocular injection of their drug.At that time of the call it was not clear whether the complaint had been submitted to bd; they are still in the process of verifying but i am submitting this conservatively.I will forward any additional information i receive, but bear in mind they may be directing the individual who reported originally to report directly to bd.Date of awareness: (b)(6)2019 catalog number: 328468.Lot number: 7325644.

Manufacturer Narrative

Investigation: customer returned photos of a poly bag of bd syringes from lot # 7325644.Customer states that there is an intraocular inflammation complaint involving bd insulin syringes.The attached photos were examined and only showed the poly bag of the syringes.The attached photos did not show the syringes therefore it is difficult to determine if there is any manufacturing defect that could had led to the reported issue.A review of the device history record was completed for batch# 7325644.All inspections and challenges were performed per the applicable operations qc specifications.There were six (6) notifications [200728235, 200727834, 200727617, 200727669, 200724457, 200727618] noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure it is difficult to determine if there is any manufacturing defect that could had led to the reported issue.

• Brand Name: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8501457
• MDR Text Key: 141576727
• Report Number: 1920898-2019-00337
• Device Sequence Number: 0
• Product Code: FMF
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 328468
• Device Lot Number: 7325644
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other