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

Catalog Number 324911

Device Problems Component Missing (2306); Out-Of-Box Failure (2311); Device Markings/Labelling Problem (2911)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the measure markings on a bd ultra-fine¿ insulin syringe were missing, before use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received (2) loose 1/2cc, 6mm syringes from the customer in support of this complaint.One syringe was returned with the hub-needle/shield assembly separated from the barrel.The barrel was examined and exhibited a piece of the barrel broken off ranging from the 0-10 unit marking, which could cause the hub assembly to separate from the barrel.The remaining syringe was examined and exhibited no scale printed on the barrel.A review of the device history record was completed for batch# 6195900.All inspections and challenges were performed per the applicable operations qc specifications.Upon evaluation by qe (b)(4), similar findings to those documented during initial investigation performed at bd (b)(4) were noted.For the sample exhibiting missing scale markings, probable root cause is a lack of ink permanency, either due to static electricity or a adulterant, such as lube, along the exterior surface of the syringe barrel.When either occurs, it increases the possibility that the ink will not adhere to the syringe barrel properly.The result can be a wide variety of scale print defects, from simply rubbing off too easily to being completely missing.The sample which exhibited the needle hub separate and the broken syringe barrel, this is likely due to damage to the barrel during infeed into the prep dial.When instances such as this occur, it increases the chance that the barrel tip will not be securely affixed with the hub/cannula/shield assembly.As is noted with this sample, the damage to the barrel wall caused the tip of the barrel to not have the correct angularity to sufficiently complete the snap-fit connection.Based on the samples / photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (broken barrel and missing scale) investigation conclusion: probable root cause was noted to be the barrel likely being broken in the prep dial prior to assembly.Possible root causes for missing scale markings include: damage to the pad print drum not touching the pad for ink transfer pad heat set incorrectly print head timing out of adjustment capa (b)(4) was initiated by the (b)(4) plant to address print related defects and their associated root cause(s).Batch# 6195900 was manufactured prior to implementation of any corrective/preventive actions associated with this capa.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7237522
• MDR Text Key: 98914148
• Report Number: 1920898-2018-00021
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: 00382903249114
• 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
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324911
• Device Lot Number: 6195900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other