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

Catalog Number 328438

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 the bd insulin syringe with the bd ultra-fine¿ needle hub separates from the device.1 of 2 related files.The following information was provided by the initial reporter: consumer reported found 2 syringes from this box needle shields hard to remove.When forced the shield off syringe the needle assembly stayed within the shield.

Event Description

Mat# 328438, batch# 8239907.It was reported by the consumer that found 2 syringes from this box; needle shields hard to remove.When forced the shield off syringe, the needle assembly stayed within the shield.Verbatim: consumer reported found 2 syringes from this box needle shields hard to remove.When forced the shield off syringe the needle assembly stayed within the shield.Discarded the shield with needle stuck inside.Has the 2 syringes to send back with mailing kit lot # 8239907.Catalog# 328438.Date of event 08/30/2023.Date of event 08/29/2023.Sample status awaiting sample dc.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-oct-2022.H.6: investigation summary: samples were received and an investigation was performed.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.H3 other text : see h.10.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: PISTON 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17752921
• MDR Text Key: 323500056
• Report Number: 1920898-2023-00625
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: (01)00382908438032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 328438
• Device Lot Number: 8239907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• 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