MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PLASTIPAK SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Occupation: product quality surveillance sr.Specialist.Device evaluated by mfr: 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 that "cuvitru" was drawn up into the unspecified bd plastipak¿ syringe for infusion before a foreign residue was noticed in the solution.The following information was provided by the initial reporter: "patient drew cuvitru up into syringe to infuse and noticed a residue in the solution.Patient did not use it and it was discarded so no sample available.Additional information received on 07-feb-2019: was any residue observed in the cuvitru solution before drawing into the syringe? response: it was noticed once it was drawn up into the syringe and not when just in the vial.How long after drawing into the syringe was the residue observed? response: very soon after it was drawn up.What type of syringe was used (brand)? response: 50 ml bd plastipak.".

Manufacturer Narrative

Investigation: two photos were received by the quality team for evaluation.Upon visual inspection, both photos show a syringe with the bottom part of the stopper covered with what appears excess of silicone but cannot be confirmed without the actual sample.The analysis of the sample would help to confirm the foreign matter.A device history record could not be evaluated as the lot number is unknown.The quality was unable to perform a thorough investigation as no actual sample, material number, or lot/batch number were provided, therefore the root cause cannot be determined.

Event Description

It was reported that "cuvitru" was drawn up into the unspecified bd plastipak¿ syringe for infusion before a foreign residue was noticed in the solution.The following information was provided by the initial reporter: "patient drew cuvitru up into syringe to infuse and noticed a residue in the solution.Patient did not use it and it was discarded so no sample available.Additional information received on 07-feb-2019: 1.Was any residue observed in the cuvitru solution before drawing into the syringe? response: it was noticed once it was drawn up into the syringe and not when just in the vial.2.How long after drawing into the syringe was the residue observed? response: very soon after it was drawn up.3.What type of syringe was used (brand)? response: 50 ml bd plastipak.".

• Brand Name: UNSPECIFIED BD PLASTIPAK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8479001
• MDR Text Key: 147057305
• Report Number: 2243072-2019-00648
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other