MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

Catalog Number 328438

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. 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 bd insulin syringe with bd ultra-fine¿ needle had "the stopper separated from the plunger on two syringes". No serious injury or medical intervention reported.

Manufacturer Narrative

Samples were returned for evaluation. Customer returned (2) loose 3/10cc insulin syringes. Customer states stopper came away from the plunger rod. The returned syringes were examined and neither syringe exhibited the stopper separated; no damage was observed on the barrel. One syringe exhibited a broken thumbpress. Sample was forwarded to manufacturing (holdrege) on 7 september 2018 for further review. On11sep2018, holdrege received two (2) loose 0. 3ml, 8mm syringes from an unreported batch number. All samples are decontaminated per hstr-17 prior to being evaluated. Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted. The damage to the sample exhibiting the broken plunger rod (missing the thumb-press) was noted to have multiple stress points within the material resulting in the device being rendered inoperable for the end user. Additionally, during the device evaluation, it was noted that one returned sample was noted to have adhesive run-off onto the syringe hub, resulting in a difficult to remove shield. Probable root cause for this defect is likely a missed cannulation for the part prior to this hub during manufacturing on the needle lines. When this type of event occurs, adhesive from one part, which does not get applied, can be applied in addition to the normal amount of adhesive of the subsequent part. (b)(4) was initiated by the (b)(4) plant to address shield difficult to remove the associated root cause(s). Based on the samples/photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure - broken plunger. Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure - stopper separation. Root cause cannot be determined for the stopper separation issue at this time as the issue is unconfirmed. Probable root causes: for broken plungers dry barrels (insufficient silicone) from the prep dial that result from a silicone gun not firing. Insufficient silicone leads to difficulty exercising the plunger, and can thereby result in broken plungers. Plunger screw jams that would damage plungers, i. E. , they break plungers. Bowed plungers that do not get seated, and get broken off at the delrin wheel. Dhr could not be performed as the lot number was not provided. Severity: s_1__; occurrence: a complaint history check could not be performed for the defect/condition reported since the lot number was not provided.

Event Description

It was reported that bd insulin syringe with bd ultra-fine needle had "the stopper. Separated from the plunger on two syringes". No serious injury or medical intervention reported.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7700441
• MDR Text Key: 114691911
• Report Number: 1920898-2018-00513
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 328438
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/18/2018 Patient Sequence Number: 1