MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-STRIP¿ ADHESIVE SKIN CLOSURES; STERI-STRIP SKIN CLOSURES

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoxia (1918); Pleural Effusion (2010)

Event Date 10/13/1999

Event Type  Injury  

Event Description

The following information was received in a journal article (unilateral pleural effusion complicating central venous catheterisation): a neonatal patient was delivered vaginally at twenty-six weeks gestation and underwent mechanical ventilation for surfactant deficient lung disease and later for poor respiratory effort.The patient was fed parenterally through peripheral lines.At sixteen days of age, when vascular access became a problem, a 27-gauge silastic catheter (vygon (uk) ltd, cirencester, gloucestershire gl7 1pt, uk) was passed into the right atrium through the right external jugular vein, and its position was confirmed radiologically.On the nineteenth day, the patient suddenly became hypoxic (arterial po2 30 mm hg) and failed to respond to increased ventilatory support.Radiographic contrast examination disclosed a right pleural effusion and showed that the tip of the catheter was in the right pulmonary artery.Approximately 15ml of straw-colored fluid was aspirated from the right pleural cavity, and the central venous catheter was removed.Oxygenation improved dramatically and an uneventful recovery was made.The central venous catheter was secured with 2cm 3m steri-strip¿ adhesive skin closures (catalog, lot unspecified) crisscrossed under the catheter close to the insertion site.An additional steri-strip overlapped the insertion site.The entire length of catheter was loosely coiled and secured to the skin using 3 cm 3m¿ steri-strip¿ reinforced adhesive skin closures.A 2 × 2 cm gauze sponge (brand unspecified) was placed under the hub.A transparent semipermeable dressing (brand unspecified) was fitted over the insertion site and the entire coiled catheter and the hub.Recommendations made by the author include: "to prevent onward catheter movement, we suggest: (a) four or five overlapping 2 cm steri-strips be applied starting close to the insertion site to secure the catheter to the skin; (b) a square of transparent semipermeable dressing be fitted over the insertion site and steri-strips; (c) the entire length of the catheter is secured to the patient (the catheter is initially loosely coiled and later secured to the skin using narrow strips of transparent semipermeable dressings).".

Manufacturer Narrative

A1, a2, a5-a6: not provided.B3: the date of event was not provided; therefore, entered the date that the article was accepted for publication.D4 & h4: no product lot number was provided and no sample was available.Without a lot number, expiration date and manufacture date could not be determined.H10: a catalog number, lot number and sample were not provided.A medical complaint history review was completed for 3m steri-strip¿ adhesive skin closures and no trend was seen.Complaints will continue to be monitored.The steri-strips were utilized as a securement device and not according to the indications for use noted in the ifu.There fore this event is being reported as a potebtial use error.Per the product ifu: indications for use: steri strip skin closures are indicated for use as a skin closure device in the treatment of lacerations and surgical incisions.To be used by medical professionals.Steri strip skin closures may also be used in conjunction with skin sutures and staples or after their removal for wound support.

• Brand Name: 3M¿ STERI-STRIP¿ ADHESIVE SKIN CLOSURES
• Type of Device: STERI-STRIP SKIN CLOSURES
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000
• MDR Report Key: 18583233
• MDR Text Key: 333772120
• Report Number: 2110898-2024-00006
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/25/2024
• 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
• Treatment: DRESSING (BRAND NAME UNKNOWN); SPONGE GAUZE
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Weight: 1 KG