MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE; SYRINGE AND NEEDLE

Catalog Number 309644

Device Problems Air Leak (1008); Protective Measures Problem (3015)

Patient Problem No Code Available (3191)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using a 10 ml bd luer-lok¿ syringe with 20 g x 1 in.Bd precisionglide¿ needle on a dialysis catheter, it was noticed that the tip of the plunger was malformed which caused air to enter the dialysis catheter.The patient was transferred to a hospital where the dialysis catheter was exchanged.The patient remained inpatient at the hospital for several days after the catheter was replaced.

Manufacturer Narrative

Results: a sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6001872.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• 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: 5702427
• MDR Text Key: 46662487
• Report Number: 1213809-2016-00022
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• 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
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 309644
• Device Lot Number: 6001872
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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): Hospitalization; Required Intervention