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

Catalog Number 328519

Device Problems Component Missing (2306); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

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 before use a bd insulin syringe with the bd ultra-fine¿ needle was found with package integrity.Consumer also states that the shield was missing from the syringe.There was no report of medical intervention needed.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

Event Description

It was reported that before use a bd insulin syringe with the bd ultra-fine¿ needle was found with package integrity.Consumer also states that the shield was missing from the syringe.There was no report of medical intervention needed.

Event Description

It was reported that before use a bd insulin syringe with the bd ultra-fine¿ needle was found with package integrity.Consumer also states that the shield was missing from the syringe.There was no report of medical intervention needed.

Manufacturer Narrative

Investigation summary: customer returned partially crushed (1) 1cc 31g 6mm relion syringe in an open polybag from lot number 7093923.See attached photo.Customer states that when taking the syringe out of the package a needle stick occurred and noticed the needle was bent.The returned syringe was examined and it was observed to have no shield and the cannula was bent, which exposes the cannula and could cause a needle stick.A review of the device history record was completed for batch# 7093923.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200693944] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Investigation conclusion: possible root causes: 1.Defect could have occurred at the prep dial of the metro assembly machine loss of back pressure on the in-feed rail may cause the barrel to become pinched at the rail / prep dial junction.The trip gate eye sensor should detect low rail conditions and activate the trip gate to prevent the barrels from being loaded into the prep dial and possibly jamming at that location.2.Infeed dial at barrel printers.3.Loss of back pressure at infeed rail also at form fill & seal.

• Brand Name: BD INSULIN SYRINGE WITH THE 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: 7629386
• MDR Text Key: 112296430
• Report Number: 1920898-2018-00447
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• 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: 08/27/2018

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: 328519
• Device Lot Number: 7093923
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 06/04/2018
• Supplement Dates FDA Received: 07/31/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other