MAUDE Adverse Event Report: BD (SUZHOU) PRN ADAPTER

Catalog Number 388638

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that prn adapter cap disconnected and leaked during use.The following information was provided by the initial reporter: the patient underwent laparoscopic bilateral inguinal hernia tension-free repair under general anesthesia on (b)(6) 2020.Before the operation, a y-type indwelling needle was placed in the right forearm and a heparin cap was connected to complete the postoperative infusion.Connected the infusion set to the tube and fixed the heparin cap for infusion treatment the next day.At 9:00 on (b)(6) 2020, the nurse disinfected the heparin cap of the y-type indwelling needle on the right forearm of the patient and connected the infusion tube.The infusion was normal and no abnormalities were found.After 2 hours, the patient found that the sheets were soaked with the medicinal solution and called the nurse.The nurse checked and found that the entire rubber plug of the heparin cap connected to the infusion fell off, causing the medicinal solution to leak out.Immediately replaced the heparin cap, connected the infusion and continue the infusion normally, and explained the changes to the patient and family members.A little of the fluid was lost without causing other injuries.

Event Description

It was reported that prn adapter cap disconnected and leaked during use.The following information was provided by the initial reporter: the patient underwent laparoscopic bilateral inguinal hernia tension-free repair under general anesthesia on (b)(6) 2020.Before the operation, a y-type indwelling needle was placed in the right forearm and a heparin cap was connected to complete the postoperative infusion.Connected the infusion set to the tube and fixed the heparin cap for infusion treatment the next day.At 9:00 on (b)(6) 2020, the nurse disinfected the heparin cap of the y-type indwelling needle on the right forearm of the patient and connected the infusion tube.The infusion was normal and no abnormalities were found.After 2 hours, the patient found that the sheets were soaked with the medicinal solution and called the nurse.The nurse checked and found that the entire rubber plug of the heparin cap connected to the infusion fell off, causing the medicinal solution to leak out.Immediately replaced the heparin cap, connected the infusion and continue the infusion normally, and explained the changes to the patient and family members.A little of the fluid was lost without causing other injuries.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9077538.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.The complaint could not be confirmed and root cause is undetermined.Capa#1389644 was initiated.H3 other text : see h.10.

• Brand Name: PRN ADAPTER
• Type of Device: PRN
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9933520
• MDR Text Key: 192382421
• Report Number: 3006948883-2020-00119
• Device Sequence Number: 1
• Product Code: LHI
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 388638
• Device Lot Number: 9077538
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other