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

Catalog Number 328519

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 plunger rod of a bd insulin syringe with the bd ultra-fine¿ needle is loose and falls out.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on (b)(6) 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 the plunger rod of a bd insulin syringe with the bd ultra-fine¿ needle is loose and falls out.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that the plunger rod of a bd insulin syringe with the bd ultra-fine¿ needle is loose and falls out.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: two evaluations were carried out.Franklin lakes investigation summary: customer returned (4) 1cc, 6mm, 31g relion syringes in an open poly bag from lot#: 8022941.Customer states that the plunger rod is loose and falls out of the syringe.All returned syringes were examined and all exhibited a missing stopper which could cause the plunger rod to fall out of the barrel.No damage to the plungers was observed.Samples were forwarded to manufacturing (holdrege) on 13jul2018 for further review.Holdrege investigation summary: on 18jul2018, holdrege received four (4) 1ml, 6mm, 31g relion syringes in an opened polybag from batch#: 8022941.All samples were decontaminated per hstr-17 prior to evaluation.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.Additionally, all samples were disassembled and the plunger rod visually inspected.No abnormal findings were noted from this evaluation at this time.Possible root cause(s) include, but are not limited to: a jam on the metro during plunger rod/stopper assembly, a supplier related molding or cut defect of the stopper prior to assembly and/or a part in the dial pathway at the point of assembly that inhibited completion.A review of the device history record was completed for batch#: 8022941.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger rod loose on lot#: 8022941.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (missing stopper).Based on the above, 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.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7648192
• MDR Text Key: 112850699
• Report Number: 1920898-2018-00461
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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: 8022941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other