MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML LUER-LOK¿ TIP; SYRINGE, LUER-LOK

Catalog Number 302995

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that during blood transfer with a bd syringe 10ml luer-lok¿ tip ,the connector tip broke/snapped mid-way through and blood sprayed in her face, mouth, and down her neck.The user is receiving infectious disease testing.

Manufacturer Narrative

Results: bd received three (3) unused samples from an additional luer lok¿ 10ml syringe (lot number 7082511) from the customer facility.Luer lok¿ 10ml syringe (lot number 7088580) involved in this incident was not received by bd for analysis.The customer had indicated that the actual complaint devices were discarded immediately following the incident.Three unused samples were inspected utilizing ct scanning of the syringe dimensions in relationship to the model drawing.All results were observed to be within the acceptable tolerance specifications.One photo was submitted by the customer that showed an unused btd connected to an unused luer lok¿ 10ml syringe.Ten random samples were inspected via ct scanning in flks.All results were observed to be within the acceptable tolerance specifications.Only one data point from one of the samples showed a slightly smaller luer taper, which is mostly attributed to the higher sensitivity/resolution of the ct scan test method, yet when rounded to the spec significant figure (one decimal place) is acceptable.It is also considered from the design perspective that this difference in taper would not induce or create the crack reported.In addition, the assembly interaction with the btd device confirmed no voids in the mating surfaces.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7088580 & 7082511.Conclusion: without an actual sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Manufacturer Narrative

Samples received with an additional lot# 7082511.Manufacture date: 04/04/2017; exp: 2/28/2022.Udi#: (b)(4).

• Brand Name: BD SYRINGE 10ML LUER-LOK¿ TIP
• Type of Device: SYRINGE, LUER-LOK
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6828505
• MDR Text Key: 83940318
• Report Number: 1213809-2017-00074
• Device Sequence Number: 1
• Product Code: FMF
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/04/2017
• Device Catalogue Number: 302995
• Device Lot Number: 7082511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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