MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 1ML; PISTON SYRINGE

Catalog Number 303172

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd plastipak¿ 1ml, the device experienced foreign matter in the fluid path of the barrel.The following information was provided by the initial reporter.The customer stated: according to the customer¿s report, lots of black fms were found inside the barrel.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/18/2021.H.6.Investigation: one sample and photo received for investigation, upon visual inspection of the sample received it can be observed there is black foreign matter embedded in the barrel of the syringe.No other defects can be noticed.Possible root cause for embedded foreign matter may appear during molding process, due to entrance of a particle in the raw material used to mold the parts.A foreign particle exposed to the temperatures that polypropylene reaches during molding process may burn, leading to a black burnt particle.This same defect is shown in pictures provided by customer.Before the injection machine is restarted up it is purged until the material is acceptable rejecting the first pieces.Injection machines are periodically subjected to maintenance and cleaning program.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported when using the bd plastipak¿ 1ml, the device experienced foreign matter in the fluid path of the barrel.The following information was provided by the initial reporter.The customer stated: according to the customer¿s report, lots of black fms were found inside the barrel.

• Brand Name: BD PLASTIPAK¿ 1ML
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12639235
• MDR Text Key: 276867734
• Report Number: 3003152976-2021-00690
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 303172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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