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

Catalog Number 328519

Device Problems Bent (1059); Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2017

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 a package of bd insulin syringe with the bd ultra-fine¿ needle(s) contained bent needles and one needle broke off into the vial during use.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 2nd related complaint for needle hub separates, and the 1st related complaint for needle bent before use on lot # 7037944.Investigation summary: customer returned (3) 1cc, 6mm, 31g relion syringes in an open poly bag from lot # 7037944.Customer states that the needle got stuck in the vial and the needles were bent.All returned syringes were examined and one sample exhibited a detached cannula.The barrel was examined and exhibited adhesive runoff onto the hub and little adhesive inside the hub.Both remaining samples exhibited a bent cannula and adhesive runoff onto the hub.As per manufacturing, a review of the device history record was completed for batch # 7037944.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200682644] noted that did not pertain to the complaint.Conclusion: probable root cause determined to be misalignment during application of adhesive on the needle lines.When this occurs, adhesive run over onto the hub or possible the cannula may occur.Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use.Bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff and bent cannula) capa (b)(4) was initiated by the (b)(4) plant to address adhesive run over.

• 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: 7064177
• MDR Text Key: 93692349
• Report Number: 1920898-2017-00345
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K950466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• 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: 7037944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Date Manufacturer Received: 11/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other