MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD EPILOR¿ PLASTIC LOR SYRINGE; ANESTHESIA CONDUCTION KIT

Catalog Number 405198

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

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd epilor¿ plastic lor syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the syringe had drops of what appears to be some liquid inside the syringe.Drops of what appears to be some liquid inside the syringe.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review was not performed since a lot number was not provided.H3 other text : see h.10.

Event Description

It was reported while using bd epilor¿ plastic lor syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the syringe had drops of what appears to be some liquid inside the syringe.Drops of what appears to be some liquid inside the syringe.

• Brand Name: BD EPILOR¿ PLASTIC LOR SYRINGE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14336353
• MDR Text Key: 291210186
• Report Number: 9610847-2022-00174
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K925902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405198
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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