MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SYRINGE WITH ATTACHED SAFETYGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number 305945

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/17/2018

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 that during use a bd¿ syringe with permanently attached safetyglide¿ needle malfunctioned as "the plunger rod broke." there has been three seperate encounters." the nurse was pulling air to inject into the vial to draw up the solution she needed to administer.Two ( 2) of the plungers broke in the middle and the other, the black rubber end of the plunger separated also while pulling air in." there was no report of exposure, injury or medical intervention needed.

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 returned 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 # 7257771.All inspections were performed per the applicable operations qc specifications.There were eight (8) notifications [(b)(4)] noted that did not pertain to this complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of plunger rod broke with lot #7257771 regarding item #305945 based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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 during use a bd¿ syringe with permanently attached safetyglide¿ needle malfunctioned as "the plunger rod broke." there has been three seperate encounters." the nurse was pulling air to inject into the vial to draw up the solution she needed to administer.Two ( 2) of the plungers broke in the middle and the other ,the black rubber end of the plunger separated also while pulling air in." there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD¿ SYRINGE WITH ATTACHED SAFETYGLIDE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7615535
• MDR Text Key: 112046119
• Report Number: 1920898-2018-00473
• 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
• Report Date: 07/10/2018

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: Nurse
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 305945
• Device Lot Number: 7257771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other