MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50 ML CATHETER TIP SYRINGE

Catalog Number 300867

Device Problems Break (1069); Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that abd plastipak¿ 50 ml catheter tip syringe had a cracked barrel, the following information was provided by the initial reporter, "syringe barrel cracked ( leakage of products to be injected)\ tip broken in sealed blister.".

Event Description

It was reported that abd plastipak¿ 50 ml catheter tip syringe had a cracked barrel, the following information was provided by the initial reporter, "syringe barrel cracked ( leakage of products to be injected)\ tip broken in sealed blister.".

Manufacturer Narrative

H.6.Investigation: three samples and two photo were provided to our quality engineer for investigation.Upon inspecting the product, the barrel was cracked in two of the samples and the tip broken in the third.A device history was performed for reported lot 1712217 and found one annotation that could be related to the reported malfunctions.During the assembly process, a failure was detected which cause product to become jammed in a broken feeder wheel.Once detected the mechanical team repaired the issue and impacted product was scrapped.It was determined the product problem is likely related to this failure.

• Brand Name: BD PLASTIPAK 50 ML CATHETER TIP SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8566897
• MDR Text Key: 154278595
• Report Number: 3003152976-2019-00295
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008674
• UDI-Public: 382903008674
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 300867
• Device Lot Number: 1712217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other