MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PRN ADAPTER; NEEDLELESS LUER PRN ADAPTER

Catalog Number 388638

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

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 prn adapter experienced a cap that was loose/disconnected which was noted prior to use.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2019.The nurse placed an indwelling needle in accordance with the doctor's instructions, and then unsealed a prn.It was found that the latex stopper on the back of the prn was loose and could be easily removed with hands.After taking another heparin cap, no abnormalities were found.

Manufacturer Narrative

H.6 investigation: dhr a review of the device history record revealed no irregularities during the manufacture of the reported lot # 9077538.No samples were returned, and no defective picture was returned, leakage test for retention sample results passed.The root cause cannot be confirmed.H3 other text : see h.10.

Event Description

It was reported that the prn adapter experienced a cap that was loose/disconnected which was noted prior to use.The following information was provided by the initial reporter: the patient was admitted to the hospital on (b)(6) 2019.The nurse placed an indwelling needle in accordance with the doctor's instructions, and then unsealed a prn.It was found that the latex stopper on the back of the prn was loose and could be easily removed with hands.After taking another heparin cap, no abnormalities were found.

• Brand Name: PRN ADAPTER
• Type of Device: NEEDLELESS LUER PRN ADAPTER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9537291
• MDR Text Key: 181440096
• Report Number: 3006948883-2019-01147
• 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: 01/15/2020

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
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other