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

Catalog Number 328438

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is not available for evaluation.However, a no sample investigation will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd insulin syringe with bd ultra-fine¿ needle separated from the hub and the shield was difficult to remove.Another part of the complaint states that the ¿plunger is missing the piece you depress¿.There was no report of injury or medical interventions.

Manufacturer Narrative

The initial mdr stated an incorrect "date received by manufacturer".The correct date is 04/06/2018.

Manufacturer Narrative

H.6.Investigation summary: two investigations were carried out.First investigation summary: customer returned (18) loose 3/10cc, 8mm syringes.Customer states that the needle hub separates from the syringe and the shield is difficult to remove and the plunger is missing the piece you depress.Three syringes were returned with the hub-needle/shield assembly separated from the barrel.All remaining syringes were tested to determine the shield removal forces (specs: shield removal force for 3/10cc after sterilization: 0.85-5.95 lbs.).All removal forces fall within specifications.One of these syringes also exhibited a broken thumb press on the plunger rod.Samples were forwarded to manufacturing (holdrege) on 11may2018 for further review.Second investigation summary: on 15may 2018 holdrege received eighteen (18) samples of 0.3ml syringes.All samples were decontaminated per hstr-17 and hqa - 68.Upon evaluation by qe aa, similar findings to those documented during initial investigation performed a bd franklin lakes were noted.Additionally, minor damage, to the barrel tips and the hub cores of the separated hub assemblies, was noted through visual inspection of the returned samples.Probable root cause: broken plunger.Bowed plungers that do not get seated, and get broken off at the delron wheel.Plunger screw jams that would damage plungers and break them.Probable root cause: hub separates hub core damage (seating of racks or during assembly onto the barrel) adhesive run over causing excessive force to remove the shield, disassembling the hub from the barrel.Misaligned sensor from its designated position may result in sending defective parts with gate flash and/or raised needle assemblies to packaging product.A broken plunger that gets lodged between barrel and shield carriers may cause incomplete shield assemblies.(b)(4) was initiated by the holdrege plant to address needle hub separates and their associated root cause(s).Unable to perform dhr check for needle hub separates, shield difficult to detach and missing thumb press due to unknown lot number.Severity: s_1__; occurrence: unable to perform complaint lot history check for needle hub separates, shield difficult to detach and missing thumb press due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates and broken thumb press).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (shield difficult to remove).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.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7484653
• MDR Text Key: 107356134
• Report Number: 1920898-2018-00336
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• 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
• Report Date: 06/06/2018

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: Lay User/Patient
• Device Catalogue Number: 328438
• Device Lot Number: UNKNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2108
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 04/06/2018; 04/06/2018
• Supplement Dates FDA Received: 05/11/2018; 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other