MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCKS

Catalog Number 394602

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the cap of the bd connecta¿ 3- way stopcock was loose, causing leakage during use.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the cap of the bd connecta¿ 3- way stopcock was loose, causing leakage during use.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: the device history report for lot number: 8026652, 7339855, 7335674 and 7312631 were reviewed, no related abnormalities were found.Material number: 394602 for lot: 8026652, 7339855, 7335674 and 7312631 were manufactured on feb-01-2018, dec-20-17, dec-20-17 and nov-27-17 respectively.This is the first instance of this failure mode with these lot numbers.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally samples were provided for the purpose of aiding our quality engineer's investigation, these were reviewed for damage and other abnormalities and subjected to leakage testing.Bd engineers were unable to identify any leakage or abnormalities that would likely contribute to the reported failure mode.Unfortunately the root cause for this complaint could not be determined without the ability to observe or duplicate the reported event.However, bd will continue to track and trend for this issue.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD CONNECTA¿ 3-WAY STOPCOCKS
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7739113
• MDR Text Key: 115777160
• Report Number: 9610847-2018-00248
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 394602
• Device Lot Number: 8026652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other