MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.3ML 31G X 5/16" (8MM); INSULIN SYRINGE AND NEEDLE

Catalog Number 328440

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that the rubber stoppers on a 1 bd insulin syringe with the bd ultra-fine¿ needle 0.3ml 31gx5/16" (8mm) were found slanted, preventing the rod from sliding correctly.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned (10) 3/10cc, 8mm, 31g syringes in an open poly bag from lot # 7016789.Customer states that the rubber stopper is slanted preventing the rod from sliding correctly.All returned syringes were examined and 8 out of 10 samples exhibited a deformed stopper in the barrel that can cause the plunger from moving efficiently in the barrel.As per manufacturing, a review of the device history record was completed for batch# 7016789.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted during manufacturing of the above listed batch.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (deformed stopper and plunger rod difficult to move) 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.Possible root causes for a damaged stopper include: this condition is referred to as a rolled stopper which can occur during the assembly process, when the plunger rod is being assembled in the barrel and there is inadequate (not enough) lube present in the barrel id (inner diameter) and or the stopper itself does not have enough lube on it.As a result, the stopper does not move freely in the barrel and can become stuck and deformed.There is also the possibility that the stopper starts out being misaligned on the end of the plunger rod and then gets rolled as it is being inserted inside the barrel.Rolled stoppers can also be caused by partially peeling off the stopper before insertion into the syringe barrel.As per supplier, improper stacking of rubber sheets in autoclave cart, causing pinching/deformity.Capa (b)(6) has been opened to address this issue.Holdrege investigation: on (b)(6) 2017, holdrege received ten (10) 0.3ml, 8mm, 31g syringe in opened polybag from batch# 7016789.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, it was noted that 8 of 10 samples exhibited a deformation of the stopper, as visualized within the assembled syringes.Upon disassembly of the plunger rod/stopper from the remainder of the syringe, the stoppers were noted to retain their deformed shapes previously noted.Additionally, the stoppers appeared to be 'dry', lacking the anticipated silicone and 'wet' appearance seen within sample populations from manufacturing.Dry stoppers, even with the given silicone sprayed within the interior of the barrels during manufacturing, can cause increased difficulty in performing both cycle testing as well as performance of the device itself.A review of the device history record noted no related quality notifications for any silicone related issues.Capa (b)(4) was initiated by the holdrege plant to address damaged/deformed stoppers and their associated root cause(s).Batch# 7016789 was produced prior to initiation of this capa.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.3ML 31G X 5/16" (8MM)
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6892145
• MDR Text Key: 87473929
• Report Number: 1920898-2017-00197
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/09/2017
• Device Catalogue Number: 328440
• Device Lot Number: 7016789
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other