MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER; INTERVASCULAR CATHETER

Catalog Number 381323

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 06/15/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: the complaint is unconfirmed as no photo / samples received a review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non¿conformance.If samples are received in the future the complaint will be re-opened and re-investigated.Investigation conclusion: the investigation was not able to confirm what the customer had experience as there were no returned samples/pictures for evaluation.

Event Description

It was reported that a serious injury occurred during use with a bd insyte-w¿ iv catheter.The following information was provided by the initial reporter, ((b)(6) translation) "patient, due to trauma on (b)(6) 2019 hospital, due to the need for illness, to give a retention needle, the third day of the patient complained about the rubber paste found red itching on the skin, the nurse looked at found that the skin has red rash, report the doctor, immediately dialed the retention needle, give the patient glue place with iodine volt disinfection treatment.".

• Brand Name: BD INSYTE-W¿ IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8897758
• MDR Text Key: 154559812
• Report Number: 8041187-2019-00642
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: 30382903813231
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 381323
• Device Lot Number: 8234080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR