MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 1ML ST BULK CONVENIENCE PAK; PISTON SYRINGE

Model Number	309701
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1ml st bulk convenience pak had foreign matter.The following information was provided by the initial reporter: material no: 309701, batch no: 0007599.It was reported that the syringe was dirty (according to google translation).Event description per email states: when opening the syringe tray 1 ml 1 of the syringes was "dirty" and therefore contaminated.Sample not available.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was performed for provided final lot number 0007599 and all applicable sub-assembly lot numbers.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, three picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, contamination was observed near the thumb rest on the plunger rod, outside of the fluid pathway.The foreign matter appeared to resemble oil residue from the molding process; however, this cannot be confirmed through the picture samples.Based on an evaluation of the complaints received, we believe this was an isolated incident.At this time, further action has not been determined necessary.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 1ml st bulk convenience pak had foreign matter.The following information was provided by the initial reporter: material no: 309701; batch no: 0007599.It was reported that the syringe was dirty (according to google translation).Event description per email states: when opening the syringe tray 1 ml 1 of the syringes was "dirty" and therefore contaminated.Sample not available (according to google translation).

• Brand Name: SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: 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: 10908826
• Report Number: 9610847-2020-00377
• Device Sequence Number: 19643467
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 309701
• Device Catalogue Number: 309701
• Device Lot Number: 0007599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1