MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POLY MIDLINE CATHETER 4F SL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Discolored (1170); Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds3530 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reds3530) have been reported from the same facility.
Event or Problem Description
It was reported that kit contained expired and discolored ultrasound gel.On 12/20/2019-based on preliminary evaluation, kit was likely shipped with expired us gel.
Additional Manufacturer Narrative
H11:section a through f - 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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of expired ultrasound gel within kit appears to be valid.One photo sample of an ultrasound gel packet was provided for evaluation.The complete packet label is not visible.Lot: 0416008.The expiration date appears to show 2019-09.The expiration date corresponding to the reported lot number is 10/31/2020.The photo sample will be forwarded to the manufacturing facility for further evaluation.Reynosa evaluation: complaint due to ¿expired ultrasound gel contained in kit¿ was confirmed.According with the photo evaluation performed at reynosa facility and vad field assurance evaluation it was concluded that an expired ultrasound gel was placed in the kit causing mismatch (unit label expiration date vs.Component expiration date).Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of reds3530 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reds3530) have been reported from the same facility.
Event or Problem Description
It was reported that kit contained expired and discolored ultrasound gel.12/20/2019-based on preliminary evaluation, kit was likely shipped with expired us gel.

• Brand Name: BARD POLY MIDLINE CATHETER 4F SL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9572115
• Report Number: 3006260740-2020-00032
• Device Sequence Number: 534811
• Product Code: LJS
• UDI-Device Identifier: 00801741137464
• UDI-Public: (01)00801741137464
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K001901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000716
• Device Lot Number: REDS3530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1