MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE INSULIN SYRINGES ULTRA-FINE NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number 324704

Device Problems Detachment Of Device Component (1104); Unsealed Device Packaging (1444)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter email: (b)(6).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 needle stick injury occured when the cap was off of the bd insulin syringes ultra-fine¿ needle in the unopened package causing sterility breach.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: two investigations were carried out.Franklin lakes investigation summary: customer returned (20) 1cc, 12.7mm, 29g syringes in sealed poly bags from lot # 7100916.Customer states that there was a needle stick injury due to a needle without a cap in an unopened bag.Both returned poly bags were examined and 7 out of 20 samples exhibited the shield loose in the bag with the cannula exposed.Since the cannula was exposed, a needle stick could occur.Samples were forwarded to manufacturing (holdrege) on 13jul2018 for further review.Holdrege investigation summary: on 18jul2018, holdrege received twenty (20) 1ml, 12.7mm, 29g syringes in sealed polybags from 7100916, all housed within a yellow bd home sharps container.Additionally, a photograph was provided by the complainant with this record.All samples were decontaminated prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.From the limited viewing capabilities within the sharps container, no obvious damage to the shields or polybag were noted, suggesting that these polybags were not necessarily a part of a jaw jam event on the ffs (form fill & seal) equipment.It is possible that during the packaging of the polybags into the carton, that the shubert equipment could cause such an event to happen.Further root cause(s) for defects noted within the returned samples are unable to be evaluated at this time.A review of the device history record was completed for batch# 7100916.All inspections were performed per the applicable operations qc specifications.There were three (3) notifications [200695005, 200695004, 200695049] noted that did not pertain to the complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle stick injury and the 1st related complaint for needle shield separated on lot # 7100916.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.

Event Description

It was reported that a needle stick injury occured when the cap was off of the bd insulin syringes ultra-fine¿ needle in the unopened package causing sterility breach.Found before use.No reports of serious injury or medical intervention noted.

• Brand Name: INSULIN SYRINGES ULTRA-FINE NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7636562
• MDR Text Key: 112433062
• Report Number: 1920898-2018-00436
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 324704
• Device Lot Number: 7100916
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other