MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SYRINGE BD SAFETYGLIDE¿ SAFETY NEEDLE; SAFETY ENGINEERED SYRINGE AND NEEDLE

Catalog Number 305945

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 during use a bd¿ syringe with permanently attached bd safetyglide¿ safety needle malfunctioned as "the seal detached from the plunger while pulling in air." there was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that during use a bd¿ syringe with permanently attached bd safetyglide¿ safety needle malfunctioned as "the seal detached from the plunger while pulling in air." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.

Manufacturer Narrative

Investigation summary: customer returned (140) 1ml, 13mm, 27g bd safetyglide allergy syringes in sealed blister packs from lot # 7257771, (199) 1ml, 13mm, 27g bd safetyglide allergy syringes in sealed blister packs from lot # 7257769, and (129) 1ml, 13mm, 27g bd safetyglide allergy syringes in sealed blister packs from lot # 8002819.Customer states that the seal detached from the plunger while pulling in air.Thirty samples from each of the returned lot numbers were tested and no stopper separated from the plunger rod when exercising the plunger rod.The attached photos were examined and exhibited a broken plunger rod and the stopper separated from the plunger rod.A review of the device history record was completed for batch# 8002819.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure investigation conclusion: possible root cause: insufficient silicone in the barrel.

Event Description

It was reported that during use a bd¿ syringe with permanently attached bd safetyglide¿ safety needle malfunctioned as "the seal detached from the plunger while pulling in air." there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD¿ SYRINGE BD SAFETYGLIDE¿ SAFETY NEEDLE
• Type of Device: SAFETY ENGINEERED SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7562938
• MDR Text Key: 110046953
• Report Number: 1920898-2018-00389
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 305945
• Device Lot Number: 8002819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 05/16/2018; 05/16/2018
• Supplement Dates FDA Received: 07/19/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other