MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE¿ IV INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	329424
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that "a hair was laminated in the seal" of the bd micro-fine¿ iv insulin syringe.
Event or Problem Description
It was reported that "a hair was laminated in the seal" of the bd micro-fine¿ iv insulin syringe.
Additional Manufacturer Narrative
Investigation summary: customer returned a photo of a 1cc syringe in a blister pack.Severity ranking is s1.Unable to perform complaint lot history check due to unknown lot number.Unable to perform dhr check due to unknown lot number.Investigation conclusion: the returned syringe was examined and exhibited a strand of material in the seal of the blister pack.Root cause description: it is difficult to determine the identity of this material and any possible root causes solely from the returned photo.Rationale: based on the above, no additional investigation and no capa is required at this time.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.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) bd 1cc, 12.7mm, 28g insulin syringe in a sealed blister pack from lot # 8113628.Customer states that a hair was laminated in the seal of the product.The returned syringe was examined and exhibited a dark strand of material in the seal of the blister pack.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 hair.A review of the device history record was completed for batch # 8113628.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure.Probable root cause for the fm is from passing through the vent and falling into the open trays before being sealed or from a maintenance technician entering the machine and allowing contamination to fall inside the tray loaders.
Event or Problem Description
It was reported that "a hair was laminated in the seal" of the bd micro-fine¿ iv insulin syringe.

• Brand Name: BD MICRO-FINE¿ IV INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8197802
• Report Number: 1920898-2018-00963
• Device Sequence Number: 1557233
• Product Code: FMF
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2019

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: Other
• Device Catalogue Number: 329424
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 12/06/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/24/2019; 04/16/2019
• 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