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

Catalog Number	DYNDC2610A
Health Effect - Clinical Codes	Rash (2033); Local Reaction (2035)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).

• Common Device Name: CHLORAPEP IN PICC LINE DRSG CHNG W/ BIOPTCH
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417 1880
• MDR Report Key: 8842553
• Report Number: 1417592-2019-00128
• Device Sequence Number: 205882
• Product Code: LRO
• UDI-Device Identifier: 10889942774173
• UDI-Public: 10889942774173
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDC2610A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention