MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 100CM; STOP COCK

Catalog Number 394961

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: an additional phone # was provided as (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the connecta wht 360deg tb 100cm experienced foreign matter contamination.The following information was provided by the initial reporter: the anesthesia tech was preparing morphine 10 mg iv using bd blunt fill needle, he primed the 3 way stopcock with bd posiflush saline then pushed the medication but he noticed a thread like red color foreign body in the middle of the tube.We found a thread like material inside the sterile tubing.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-29.H6: investigation summary: a device history record review was completed by our quality engineer team for provided lot number 0007931.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the sample was returned for evaluation by our quality engineer team.Through examination of the sample, foreign matter was observed on the outer portion of the product.This product is manufactured through the use of automated machines.Personnel only have contact with the product when they are loading the machine and during this loading process, gloves are worn.It is possible that this incident resulted from a defect with the raw material used for this product; however, an exact cause for this incident cannot be determined.H3 other text : see h10.

Event Description

It was reported that the connecta wht 360deg tb 100cm experienced foreign matter contamination.The following information was provided by the initial reporter: the anesthesia tech was preparing morphine 10 mg iv using bd blunt fill needle, he primed the 3 way stopcock with bd posiflush saline then pushed the medication but he noticed a thread like red color foreign body in the middle of the tube.We found a thread like material inside the sterile tubing.

• Brand Name: CONNECTA WHT 360DEG TB 100CM
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11061179
• MDR Text Key: 226846118
• Report Number: 9610847-2020-00423
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 394961
• Device Lot Number: 0007931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1