MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTE WHT; STOPCOCK

Catalog Number 394501

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

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.(b)(4).

Event Description

It was reported that foreign matter was found in the connecta q-syte wht packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: "fm was found in a package and this affected product was thus not used.".

Event Description

It was reported that foreign matter was found in the connecta q-syte wht packaging.The following information was provided by the initial reporter, translated from japanese to english: "fm was found in a package and this affected product was thus not used.".

Manufacturer Narrative

H.6.Investigation: a complaint was received of foreign matter in the packaging.A photo and sample were provided for investigation.Black specks of foreign matter were found inside the packaging, the customer complaint was confirmed.A device history record review was completed by our quality engineer team for provided lot number 0036890.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.A root cause could not be determined.A possible root cause for this failure is an error in the manufacturing process.This is the first complaint for foreign matter on material 394501 & batch 0036890.

• Brand Name: CONNECTA Q-SYTE WHT
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11381302
• MDR Text Key: 233967376
• Report Number: 9610847-2021-00083
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 394501
• Device Lot Number: 0036890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1