MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE, ARTERIAL BLOOD COLLECTION KIT; BLOOD COLLECTION SET

Catalog Number 364413

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for sterile package breach with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for sterile package breach was not observed.A review of the manufacturing records was completed for the incident lot #5114312 and no issues were identified.Conclusion: confirmed complaint.An absolute root cause for this incident cannot be determined.(b)(4) was opened previously for a similar defect.

Event Description

It was reported that individual packages for bd vacutainer® bd preset¿ slip tip syringe with attached needle, arterial blood collection kit 23g x 1 in were not sealed.No injury or medical intervention.

• Brand Name: BD PRESET¿ SLIP TIP SYRINGE WITH ATTACHED NEEDLE, ARTERIAL BLOOD COLLECTION KIT
• Type of Device: BLOOD COLLECTION SET
• 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: 7084401
• MDR Text Key: 94509806
• Report Number: 9617032-2017-00215
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/13/2017

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: 364413
• Device Lot Number: 5114312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2015
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• 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