MAUDE Adverse Event Report: BECTON DICKINSON BD¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 59012933

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 04/08/2022

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.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 2 bd¿ infusion sets had flow issues during use.The following information was provided by the initial reporter: "the flow rate was error.The customer assumed that the spike tip or roller clamp was out of control.".

Event Description

It was reported that 2 bd¿ infusion sets had flow issues during use.The following information was provided by the initial reporter: "the flow rate was error.The customer assumed that the spike tip or roller clamp was out of control.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 27-apr-2022.H.6.Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally, a sample was received for to aid in our investigation.Our engineers subjected the returned device to high pressure fluid testing while the tubing was clamped.During the course of testing the clamp was able to maintain a seal.Further visual observation was conducted on the clamp component, which was unable to identify any obvious abnormalities or deformities.Finally a destructive dissection of the tubing was conducted to adequately measure the interior and exterior diameter of the tubing at multiple intersections.All tested sections return values that were within the product specifications.Unfortunately, our engineers were not able to confirm the reported non-conformance based on the available data.Without the ability to replicate the reported non-conformance our engineers were not able to determine a root cause for this event.A total of 60 house samples of the complaint product (iv set an120 w/o bp, lot no.2202071, 2202093, 2202196, 2203076, 2203141 & 2203171) was checked and there was no defective product found in them.

• Brand Name: BD¿ INFUSION SET
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14289765
• MDR Text Key: 290959743
• Report Number: 2243072-2022-00618
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 59012933
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• 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