MAUDE Adverse Event Report: BECTON DICKINSON FEMALE LL ADAPTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 1029-104-090

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0024076.Medical device expiration date: na.Device manufacture date: 2020-01-24.Medical device lot #: 0024077.Medical device expiration date: na.Device manufacture date: 2020-01-24.Medical device lot #: 0104784.Medical device expiration date: na.Device manufacture date: 2020-04-13.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 1 female ll adaptor each from lots 0024076, 0024077, and 0104784 had damaged, bent tube caps.The following information was provided by the initial reporter: "for the in-0101183: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state.No patient injury.¿ and for the in-0103020: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state.No patient injury.¿ and for the in-0103130: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state.No patient injury.¿".

Event Description

It was reported 1 female ll adaptor each from lots 0024076, 0024077, and 0104784 had damaged, bent tube caps.The following information was provided by the initial reporter: "for the in-0101183: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state.No patient injury.¿ and for the in-0103020: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state.No patient injury.¿ and for the in-0103130: ¿during a pre-use check, the customer noticed the cap was connected to the tube tip in a bent state.No patient injury.¿".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/6/2021.H.6.Investigation: four samples and two photos were returned by the customer.Upon visual inspection, it could be observed that the 1029-104-090 caps were bent, no other defects were observed.The customer's complaint that the cap was connected to the tube tip in a bent state was verified.The device history record review of the lots supplied with the complaint.800 pieces were visually inspected during the production of each lot with no defects observed.This failure mode has not been observed during validation or production of the component.The samples were inspected for conditions that would indicate potential root causes for the bent condition coming from molding or material handling.¿ the molding process was eliminated from consideration due to the bent condition not being consistent in orientation.There are no root causes from molding that could be identified that would cause this condition.¿ the material handling process was eliminated from consideration since there were no marks (dents or scratches) indicating the part experienced a force to bend or distort the bond pocket.The root cause for the bent components could not be determined since the condition does not have any molding or packaging potential root causes.

• Brand Name: FEMALE LL ADAPTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12513544
• MDR Text Key: 272725650
• Report Number: 2243072-2021-02362
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1029-104-090
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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