MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP; PISTON SYRINGE

Catalog Number 367342

Device Problem Product Quality Problem (1506)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Fda notified: the initial reporter also notified the fda via medwatch (b)(4).Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation and testing and upon completion, no issues were observed relating to the iv needle not retracting as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for the iv needle not retracting with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.

Event Description

It was reported that after use a bd syringes with precisionglide needle and luer-lok tip malfunctioned as "the butterfly needle did not retract and caused a needle stick injury.There was no report of medical intervention provided or protocol for needle stick injury activated.

Manufacturer Narrative

Correction to medwatch detail report: the med watch number has been updated to the corrected number 0800040000-2018-8025.

• Brand Name: BD SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7567039
• MDR Text Key: 110004661
• Report Number: 1024879-2018-00233
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 367342
• Device Lot Number: 8043768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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
• Patient Outcome(s): Other