MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM

Catalog Number 328506

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 during use of the bd relion® insulin syringe 1 ml, 31 g x 8 mm the consumer experienced a retained needle in abdomen consumer able to retrieve needle with tweezers.With the second draw of insulin, the needle stayed in vial.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: bd received samples from the customer for investigation.Two investigations were performed.11/15/2017 in (b)(4) and 11/21/2017 in (b)(4).The samples were subjected to visual, microscopic and violet light evaluations.The customer's indicated failure mode for needle detaching with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: capa (b)(4) was initiated by the (b)(4) plant to address adhesive runover and it's associated root cause(s).The incident lot was produced prior to implementation of corrective/preventive actions.

Manufacturer Narrative

Updated date of occurrence.Complaint was opened on (b)(6) 2017.Per gen notes in crs, the date of occurrence was "yesterday".This would make the date of occurrence (b)(6) 2017.

• Brand Name: BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6969908
• MDR Text Key: 90798353
• Report Number: 1920898-2017-00275
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328506
• Device Lot Number: 7044713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other