MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP. BD ECLIPSE¿ NEEDLE; BLOOD GAS ANALYSIS SYRINGE

Catalog Number 364391

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

Results bd received samples and photos from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for a breach in sterility from a hole in the package, with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm how or when the hole in the packaging occurred.

Event Description

It was reported that bd preset¿ syringe with bd luer-lok¿ tip.Bd eclipse¿ needle had a breach of package sterility.No injury or medical intervention.

• Brand Name: BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP. BD ECLIPSE¿ NEEDLE
• Type of Device: BLOOD GAS ANALYSIS SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7088726
• MDR Text Key: 94755418
• Report Number: 9617032-2017-00584
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

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 Expiration Date: 05/31/2017
• Device Catalogue Number: 364391
• Device Lot Number: 5148397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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