MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of jucrx196 showed no other similar product complaint(s) from this lot number.

Event Description

Reportedly, a foreign object was observed on sterile packaging.No other information was provided.

Manufacturer Narrative

The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of foreign material within the device package was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was two photographs depicting a picc plus statlock and a physical picc plus statlock kit.The returned physical sample matched the photo samples provided.The first photograph depicted the label side of the package and the second photograph depicted the clear film side of the package.The sample was returned sealed.A brown colored foreign material was present on the foam strip and could be seen through the clear portion of the packaging.The material appeared to be a collection of fibers.Since the material was present within a sealed kit, the complaint is confirmed to be manufacturing related.As part of reinforcement for this issue, an awareness communication training was provided to manufacturing personnel involved in this operation.

Event Description

Reportedly, a foreign object was observed on sterile packaging.No other information was provided.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
• Type of Device: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8401558
• MDR Text Key: 138278443
• Report Number: 3006260740-2019-00494
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741083372
• UDI-Public: (01)00801741083372
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VPPCSPCE
• Device Lot Number: JUCRX196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1