MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY; CHLORAPEP IN PICC LINE DRSG CHNG W/ BIOPTCH

Catalog Number DYNDC2610A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Local Reaction (2035)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that patient developed reaction to chloraprep (taken from dressing change kit) and the patient required treatment with high potency steroid cream (lidex).The reaction was described as red, weeping, painful, itchy, irregular, swiping pattern rashes to the skin around the patient's right chest port.It was clarified that the patient's rashes did not follow the outline of the dressing or any other part of the dressing.The patient's port had reportedly been accessed several times and the rashes were noted to be worsening with each access.The patient's rashes had reportedly resolved.The patient does not have any known allergies.It was added that the patient had been advised to inform clinicians not to use chloraprep when accessing or changing the dressing of her port.There was no serious injury reported related to the event.Due to the reported reaction and the need for medical intervention, this medwatch is being filed.A sample is not available to be returned for evaluation.A third party notification will be completed with bd, the manufacturer of chloraprep.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that patient developed reaction to chloraprep (taken from dressing change kit).The patient reportedly required treatment with high potency steroid cream (lidex).

• Type of Device: CHLORAPEP IN PICC LINE DRSG CHNG W/ BIOPTCH
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417 1880
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8842553
• MDR Text Key: 152683016
• Report Number: 1417592-2019-00128
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942774173
• UDI-Public: 10889942774173
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNDC2610A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2019
• 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