MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA

Catalog Number 320440

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

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 foreign matter occurred after use with a bd vacutainer® push button blood collection set with pre-attached holder.The following information was provided by the initial reporter."it was reported that a case of silicone bubbles post avastin injection was confirmed.Event description per attached email states: fyi: we have just confirmed another case of silicone bubbles post avastin injection.Injection date was oct (b)(6).The pt is booked for ongoing intraocular injections, right eye.We do not have the lot # of the syringes." 1 of 2 complaints.

Manufacturer Narrative

Correction: b.5.Describe event or problem: it was reported that foreign matter occurred after use with a syringe 0.3ml 31ga 8mm tw 10bag 500 ca.The following information was provided by the initial reporter, "it was reported that a case of silicone bubbles post avastin injection was confirmed.Event description per attached email states: fyi: we have just confirmed another case of silicone bubbles post avastin injection.Injection date was oct 1/19.The pt is booked for ongoing intraocular injections, right eye.We do not have the lot # of the syringes." 1 of 2 complaints.H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 9070598.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification(b)(4) silicone outer diameter of barrel.There were two (2) notifications(b)(4) noted that did not pertain to the complaint.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.It is important to note bd only markets insulin delivery syringes for subcutaneous use.Consistent with the naming convention and scale marking of an insulin syringe, it is insulin-specific, and it is approved by health canada for the intended use of subcutaneous injection of insulin.Insulin scale mark gradations are in insulin units as opposed to ml found on general purpose syringes.Bd does not intend for its insulin syringes to be used for any purpose other than subcutaneous injection of insulin.H3 other text : see section h.10.

Event Description

It was reported that foreign matter occurred after use with a bd vacutainer® push button blood collection set with pre-attached holder.The following information was provided by the initial reporter."it was reported that a case of silicone bubbles post avastin injection was confirmed.Event description per attached email states: fyi: we have just confirmed another case of silicone bubbles post avastin injection.Injection date was (b)(6) 2019.The pt is booked for ongoing intraocular injections, right eye.We do not have the lot # of the syringes.".

• Brand Name: SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9324639
• MDR Text Key: 166593866
• Report Number: 1920898-2019-01295
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 320440
• Device Lot Number: 9070598
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other