MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 20ML LL TIP CONV PAK; PISTON SYRINGE

Model Number 305617

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

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Material no.: 305617, batch no.: 8246664.It was reported that after use of the syringe 20ml ll tip conv pak a foreign matter was adhered to the inside wall of the syringe and would not come loose after vigorous shaking.They put the syringe under magnification and stated this particle may even be an insect.The following information was provided by the initial reporter: bd syringe with a particle inside which we are confident did not come from our process.The particle is adhered to the interior wall of the syringe and would not come loose after vigorous shaking.Also, our process of filling includes a filter which would remove such a particulate therefore the particle had to be present in the syringe before we filled it.Under magnification, it appears that this particle may even be an insect part.

Event Description

Material no.: 305617 batch no.: 8246664.It was reported that after use of the syringe 20ml ll tip conv pak a foreign matter was adhered to the inside wall of the syringe and would not come loose after vigorous shaking.They put the syringe under magnification and stated this particle may even be an insect.The following information was provided by the initial reporter: bd syringe with a particle inside which we are confident did not come from our process.The particle is adhered to the interior wall of the syringe and would not come loose after vigorous shaking.Also, our process of filling includes a filter which would remove such a particulate therefore the particle had to be present in the syringe before we filled it.Under magnification, it appears that this particle may even be an insect part.

Manufacturer Narrative

H.6.Investigation: one (1) sample and two (2) photos were provided for investigation.The sample was visually examined using unaided vision and was observed to have brown foreign matter in the syringe barrel.The foreign matter was attempted to be removed using a stainless-steel probe and it was found that the brown foreign matter is embedded in the plastic.Two (2) photos were also provided for investigation.One (1) photo shows part of the syringe barrel viewed unaided with the brown foreign matter visible.The second photo shows a magnified view of the brown foreign matter.Embedded fm can occur at the startup of the injection molding process.Solidified resin within the mold and molding press may become discolored or degraded when reheated.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: SYRINGE 20ML LL TIP CONV PAK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9520975
• MDR Text Key: 192060945
• Report Number: 9610847-2019-00763
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903056171
• UDI-Public: 30382903056171
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: 08/31/2023
• Device Model Number: 305617
• Device Catalogue Number: 305617
• Device Lot Number: 8246664
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other