MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number 309623

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd syringe 1ml s/t w/ndl 27x1/2 rb had a needle through the shield that resulted in blood exposure.The following information was provided by the initial reporter: "health professional called to report that nurse received needle stick injury due to a pierced cap.".

Manufacturer Narrative

H6: investigation summary one photo was received and evaluated.The photo displayed the tip of a syringe with attached needle (p/n 309623).It was observed that the cannula was bent and sticking through the needle shield.The observed condition was non-conforming per product specification.Potential root cause for bent needle through shield defect is associated with the needle supplier¿s manufacturing process.The photo was forwarded to the needle supplier for further evaluation and investigation.Further investigation was performed at needle manufacturing site.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Although there is no further information is available about needle was recapped by customer but it could be possible that potential root cause may be associated with needle being recapped.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.

Event Description

It was reported that bd syringe 1ml s/t w/ndl 27x1/2 rb had a needle through the shield that resulted in blood exposure.The following information was provided by the initial reporter: "health professional called to report that nurse received needle stick inury due to a pierced cap.".

• Brand Name: BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12970581
• MDR Text Key: 285716381
• Report Number: 1213809-2021-00807
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096238
• UDI-Public: 30382903096238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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 Model Number: 309623
• Device Catalogue Number: 309623
• Device Lot Number: 1042356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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): Required Intervention