MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK SYRINGE

Catalog Number 300865

Device Problems Break (1069); Contamination /Decontamination Problem (2895)

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

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1811230; medical device expiration date: 2023-10-31; device manufacture date: 2018-11-13; medical device lot #: 1901245; medical device expiration date: 2023-12-31; device manufacture date: 2019-01-29.Date of event: unknown.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 when filling bd plastipak¿ syringe, dirt was noticed inside the syringe.It was also reported that stoppers of bd plastipak¿ syringe were damaged.Foreign complaints the following information was provided by the initial reporter, translated from (b)(6) to english: ¿during filling up the 50 ml syringes customer noticed filth in/on the syringe.Then the customer noticed that stopper is skewed on two syringes.¿.

Manufacturer Narrative

Investigation: two photo samples and two physical samples were provided to our quality engineer for investigation.Through visual inspection, it was observed that the stopper was incorrectly assembled to the plunger, distorted against the barrel wall in one of the received samples.When inspecting the product, no foreign matter was identified, however, the photo provided did display a foreign substance.A device history review was performed for reported lots 1811230 and 1901245, no deviations or non-conformances related to the reported issues were identified during the manufacturing process.Product undergoes a series of testing and inspections throughout the manufacturing process to avoid defects with our products.While we could not identify a direct issue for either reported malfunction, it was determined the distorted stopper occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.Currently a root cause for the foreign matter noted in the photo cannot be determined.Projects have been opened for both malfunctions to further investigate the issue and reduce any reoccurrence.

Event Description

It was reported that when filling bd plastipak¿ syringe, dirt was noticed inside the syringe.It was also reported that stoppers of bd plastipak¿ syringe were damaged.Foreign complaints the following information was provided by the initial reporter, translated from dutch to english: ¿ during filling up the 50 ml syringes customer noticed filth in/on the syringe.Then the customer noticed that stopper is skewed on two syringes.¿.

• Brand Name: BD PLASTIPAK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8487456
• MDR Text Key: 145783547
• Report Number: 3003152976-2019-00250
• Device Sequence Number: 1
• Product Code: FMF
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: SEE H.10.
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other