MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; SKIN AFFIX SURG ADHESIVE 72/CS .4ML

Catalog Number	MSC091040
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a piece of the inner glass ampule pierced the skin affix's outer case resulting in the physician sustaining a puncture injury to his unidentified right finger.The piece of glass was successfully retrieved from the physician's finger through use of forceps.The incident reportedly happened during a spinal correction procedure and multiple skin affixes were used to close the incision site.The skin affix that broke was reportedly squeezed for an unknown number of multiple times.It was denied that the vial broke on initial activation.The patient was reportedly not affected.There was no serious injury or follow-up care related to the reported event.Due to the reported incident, this medwatch is being filed.The sample has been discarded and is not available to be returned for evaluation.A root cause could not be determined at this time.Of note, the skin affix's instructions-for-use (ifu) indicates that repeated squeezing of the skin affix's case is not recommended and may cause the glass to puncture through the plastic case.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a piece of the inner glass ampule pierced the skin affix's outer case resulting in the physician sustaining a puncture injury to his unidentified right finger.The piece of glass was successfully retrieved through use of forceps.

• Common Device Name: SKIN AFFIX SURG ADHESIVE 72/CS .4ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7974508
• Report Number: 1417592-2018-00113
• Device Sequence Number: 1487894
• Product Code: MPN
• UDI-Device Identifier: 10884389953044
• UDI-Public: 10884389953044
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSC091040
• Device Lot Number: (10)P00211282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/17/2018
• 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
• Patient Age: 35 YR
• Patient Weight: 82