MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA STOPCOCK

Catalog Number 394605

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0153839, medical device expiration date: 2023-05-31, device manufacture date: 2020-06-29.Medical device lot #: 0153840, medical device expiration date: 2023-05-31, device manufacture date: 2020-06-29.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 200 bd connecta" stopcocks experienced incorrect expiration dates.The following information was provided by the initial reporter: when the dealer received the goods, it was found that the connecta's large package and the minimum package expiration time did not match.In the case that the outer packaging is 2023-5, the inner packaging appeared at the same time as 2023-4-30 and 2023-5-31.Their main appeal is whether our company can give a standard, and under the premise that the expiry date of the large package is 2023-5, the default small package's the expiry date is 5.1-5.31.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 0153840 and the review did reveal any detected quality issues during the production and labeling processes that could have contributed to this reported incident.To aid in the investigation of this issue, picture samples were provided.The pictures revealed the labeling discrepancy for lot number 0153839 but not 0153840.In response to the incident related to lot 0153839, an update to the production process has been made.Through review of the current manufacturing process, an opportunity was detected during shift change for potential labeling defects.An update was made to ensure that during the shift, line clearance is required as well as verification and registration of the manufacturing and expiration date.Please note that the product in question can be used as the expiration date is between the acceptable period (three years), the month printed was incorrect, but it does not affect the device so long as it is used prior to the date printed on the unit packaging.H3 other text : see h.10.

Event Description

It was reported that 200 bd connecta¿ stopcocks experienced incorrect expiration dates.The following information was provided by the initial reporter: when the dealer received the goods, it was found that the connecta¿s large package and the minimum package expiration time did not match.In the case that the outer packaging is 2023-5, the inner packaging appeared at the same time as 2023-4-30 and 2023-5-31.Their main appeal is whether our company can give a standard, and under the premise that the expiry date of the large package is 2023-5, the default small package's the expiry date is 5.1-5.31.

• Brand Name: BD CONNECTA STOPCOCK
• 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: 10855667
• MDR Text Key: 226855095
• Report Number: 9610847-2020-00357
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 394605
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1